FDA.reportPublic FDA data

Cisatracurium

Product NDC
63323-416
11-digit product format
633230416
Labeler code
63323
Product ID
63323-416_0431da49-a804-457c-a823-66d8862db3f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CISATRACURIUM BESYLATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA203182
Marketing category
ANDA
Marketing start
2015-02-26
Substance
CISATRACURIUM BESYLATE
Active strength
2 mg/mL
Pharmacologic classes
Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cisatracurium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CISATRACURIUM BESYLATE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii80YS8O1MBS
Rxcui199211, 199212, 1730194

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bde27158-d1b9-e941-8af6-709c63f1bc54Product name920200925

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-416-01Cisatracurium5 mL in 1 VIALINJECTION, SOLUTION59
63323-416-05Cisatracurium10 in 1 CARTONINJECTION, SOLUTION109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-416-01ML - Milliliter63323-416a0e10ca9-d28b-45e3-9e90-989e2bf2cb6812025-08-11
63323-416-05ML - Milliliter63323-416843f3271-24f3-4718-b5b0-e42787448e4212015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CISATRACURIUM BESYLATEACTIVE INGREDIENT80YS8O1MBSCISATRACURIUM (CISATRACURIUM BESYLATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
CISATRACURIUMACTIVE MOIETYQX62KLI41NCISATRACURIUM (CISATRACURIUM BESYLATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
BENZENESULFONIC ACIDINACTIVE INGREDIENT685928Z18ACISATRACURIUM (CISATRACURIUM BESYLATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCISATRACURIUM (CISATRACURIUM BESYLATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-416CISATRACURIUM (CISATRACURIUM BESYLATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]9Current NDC, Legacy NDC, 2 package rows20250323_f78a07e2-0d3b-4460-b29e-8c10c90afbda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199211cisatracurium 2 MG/ML Injectable SolutionPSNf78a07e2-0d3b-4460-b29e-8c10c90afbda9
1730194cisatracurium besylate 10 MG in 5 ML InjectionPSNf78a07e2-0d3b-4460-b29e-8c10c90afbda9
199212cisatracurium besylate 200 MG in 20 ML InjectionPSNf78a07e2-0d3b-4460-b29e-8c10c90afbda9
19921220 ML cisatracurium 10 MG/ML InjectionSCDf78a07e2-0d3b-4460-b29e-8c10c90afbda9
17301945 ML cisatracurium 2 MG/ML InjectionSCDf78a07e2-0d3b-4460-b29e-8c10c90afbda9
199211cisatracurium 2 MG/ML Injectable SolutionSCDf78a07e2-0d3b-4460-b29e-8c10c90afbda9
1730194cisatracurium (as cisatracurium besylate) 10 MG per 5 ML InjectionSYf78a07e2-0d3b-4460-b29e-8c10c90afbda9
199211cisatracurium (as cisatracurium besylate) 2 MG/ML Injectable SolutionSYf78a07e2-0d3b-4460-b29e-8c10c90afbda9
199212cisatracurium (as cisatracurium besylate) 200 MG per 20 ML InjectionSYf78a07e2-0d3b-4460-b29e-8c10c90afbda9
199212cisatracurium 200 MG per 20 ML InjectionSYf78a07e2-0d3b-4460-b29e-8c10c90afbda9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-416-01633230416015 mL in 1 VIAL5 mlHistorical
63323-416-056332304160510 VIAL in 1 CARTON (63323-416-05) / 5 mL in 1 VIAL (63323-416-01) 10 vial2015-02-260000-00-00NoNoCurrent